Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lasofoxifene · 1 trial · 1 indication
PFS is defined as the time from the date of randomization \[Visit 0 (Day 1)\] to the earliest date of first documented progression per RECIST 1.1 as determined by BICR or death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | Pre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease and who have an ESR1 mutation. |
| Reference Therapy | ACTIVE_COMPARATOR | Pre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease and who have an ESR1 mutation. |
| Name | Type | Description |
|---|---|---|
| Lasofoxifene in combination with abemaciclib | DRUG | 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day |
| Fulvestrant in combination with abemaciclib | DRUG | Fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day |
Inclusion Criteria: 1. Pre- or postmenopausal women or men. 2. Locally advanced and/or metastatic ER+ breast cancer with radiological or clinical evidence of progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease. 3. Histol...
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